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Trial Outcomes & Findings for A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis (NCT NCT00574704)

NCT ID: NCT00574704

Last Updated: 2013-07-11

Results Overview

The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was \<10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

baseline versus 2 months after baseline

Results posted on

2013-07-11

Participant Flow

Participant milestones

Participant milestones
Measure
AllQbG10
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Overall Study
STARTED
10
10
10
10
Overall Study
COMPLETED
10
10
9
10
Overall Study
NOT COMPLETED
0
0
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AllQbG10
n=10 Participants
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen
n=10 Participants
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10
n=10 Participants
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo
n=10 Participants
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Total
n=40 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
10 Participants
n=5 Participants
10 Participants
n=4 Participants
40 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age Continuous
34.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
36.5 years
STANDARD_DEVIATION 9.8 • n=7 Participants
36.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
31.0 years
STANDARD_DEVIATION 15.9 • n=4 Participants
34.6 years
STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
6 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
16 Participants
n=21 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
6 Participants
n=4 Participants
24 Participants
n=21 Participants
Region of Enrollment
Europe
10 participants
n=5 Participants
10 participants
n=7 Participants
10 participants
n=5 Participants
10 participants
n=4 Participants
40 participants
n=21 Participants

PRIMARY outcome

Timeframe: baseline versus 2 months after baseline

The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was \<10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.

Outcome measures

Outcome measures
Measure
AllQbG10
n=10 Participants
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen
n=10 Participants
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10
n=10 Participants
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo
n=10 Participants
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)
10 Factor of Increased Allergen Tolerance
Interval 1.0 to 100.0
10 Factor of Increased Allergen Tolerance
Interval 1.0 to 10.0
10 Factor of Increased Allergen Tolerance
Interval 1.0 to 10.0
1 Factor of Increased Allergen Tolerance
Interval 0.1 to 10.0

SECONDARY outcome

Timeframe: about 30 min. at each visit

Outcome measures

Outcome data not reported

Adverse Events

AllQbG10

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Allergen

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

QbG10

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
AllQbG10
n=10 participants at risk
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen
n=10 participants at risk
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10
n=10 participants at risk
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo
n=10 participants at risk
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Injury, poisoning and procedural complications
fracture of right malleolus (accident)
10.0%
1/10
0.00%
0/10
0.00%
0/10
0.00%
0/10

Other adverse events

Other adverse events
Measure
AllQbG10
n=10 participants at risk
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen
n=10 participants at risk
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10
n=10 participants at risk
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo
n=10 participants at risk
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Infections and infestations
Nasopharyngitis
40.0%
4/10
10.0%
1/10
40.0%
4/10
50.0%
5/10
Infections and infestations
Influenza
30.0%
3/10
30.0%
3/10
0.00%
0/10
0.00%
0/10
Respiratory, thoracic and mediastinal disorders
Asthma
30.0%
3/10
20.0%
2/10
0.00%
0/10
10.0%
1/10
Eye disorders
Conjunctivitis allergic
10.0%
1/10
20.0%
2/10
10.0%
1/10
20.0%
2/10
General disorders
Local reactions
20.0%
2/10
20.0%
2/10
10.0%
1/10
0.00%
0/10
Nervous system disorders
Headache
10.0%
1/10
0.00%
0/10
10.0%
1/10
10.0%
1/10
Gastrointestinal disorders
Diarrhea
0.00%
0/10
0.00%
0/10
10.0%
1/10
20.0%
2/10
Infections and infestations
Rhinitis
0.00%
0/10
10.0%
1/10
20.0%
2/10
10.0%
1/10

Additional Information

Head of Clinical Develpment

Cytos Biotechnology AG

Phone: +41 44 733 4

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60